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Taking people in RomaniaPhase 3

Testing a once-weekly drug for weight loss in adults with diabetes

Compares weekly enicepatide with placebo for weight in adults with diabetes.

Key facts

Who runs it
Hoffmann-La Roche
Where
Brasov, Bucharest, Cluj-Napoca, Craiova, Jassi, Ploiesti, and Timisoara, RomaniaSee the 7 sitesAlso in 22 other countries, 226 sites
Registry title
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Status
Recruiting
Phase
Phase 3
People taking part
1,600 people, planned
Started
23 Mar 2026
Expected to end
7 Aug 2028
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Placebo
  • Enicepatide
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes who are overweight or have obesity. It tests the weekly drug enicepatide against placebo for weight management.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Type 2 diabetes with HbA1c from 6.5% (48 mmol/mol) to 10% (86 mmol/mol) at screening, and a body mass index (BMI) of 27.0 kg/m² or higher.
Earlier treatment
Must be on stable oral diabetes treatment for at least 3 months, or diet and exercise alone. Must have tried to lose weight with diet or exercise at least once without success. Cannot have used any GLP-1 receptor agonist-based drug within 6 months before randomization. DPP-4 inhibitors are not allowed.
Biomarker or test result
HbA1c from 6.5% (48 mmol/mol) to 10% (86 mmol/mol) on a laboratory test at screening.

Main reasons for not taking part

  • Type 1 diabetes, or ever had ketoacidosis
  • Severe low blood sugar in the last 6 months, or not noticing low blood sugar
  • Weight change of more than 5 kg (11 lb) in the last 3 months
  • Obesity caused by another hormone disease or by a genetic condition
  • Heart attack, stroke, unstable angina or hospital stay for heart failure in the last 3 months

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
  • Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy
  • Body mass index (BMI) ≥27.0 kg/m\^2
  • History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Who cannot take part

  • History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
  • Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
  • Self-reported change in body weight >5 kg within 3 months prior to screening
  • Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed
  • Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
  • Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
  • Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
  • Poorly controlled hypertension at screening
  • At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
  • Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)

Where in Romania

Also in 22 other countries, 226 sites

  • Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.Brasov, RomaniaTaking people
  • Nicodiab S.R.L.Bucharest, RomaniaTaking people
  • Spitalul Clinic Judetean De Urgenta ClujCluj-Napoca, RomaniaTaking people
  • Top Diabet S.R.L.Craiova, RomaniaTaking people
  • Consultmed S.R.L.Jassi, RomaniaTaking people
  • Diabmed Dr. Popescu Alexandrina S.R.L.Ploiesti, RomaniaTaking people
  • Spitalul Clinic Judetean De Urgenta Pius Brinzeu TimisoaraTimisoara, RomaniaTaking people

About the trial

What the trial wants to find out

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).

The 4 groups in the trial

  • Arm 1: PlaceboPlacebo, for comparison

    Treatment: Placebo

  • Arm 2: Enicepatide Dosing Regimen 1Treatment being tested

    Treatment: Enicepatide

  • Arm 3: Enicepatide Dosing Regimen 2Treatment being tested

    Treatment: Enicepatide

  • Arm 4: Enicepatide Dosing Regimen 3Treatment being tested

    Treatment: Enicepatide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes
Plain-language title
Testing a once-weekly drug for weight loss in adults with diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 10 November 2026.
Record updated
9 November 2026